Vitale

Basic Information

• Brand Name: Vitale
• Primary DI: 00850005565185
• Version / Model: 22000
• Catalog Number: 22000
• Company Name: CELLERA LLC
• Labeler DUNS: 960091929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-24
• Public Version: 4
• Public Version Date: 2023-03-29
• Public Version Status: Update
• Public Device Record Key: 976c75ad-b7a4-4deb-b7e8-a5bc3f24cb2e

Device Description

Vitale Collagen Powder, 1 gram/packet, 10 packets/box, 10 boxes/case, 8 cases/overpack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGN	Dressing, Wound, Collagen	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Collagen wound matrix dressing	A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850005565208	GS1	overpack	8	Not in Commercial Distribution	2023-03-28
Package	10850005565199	GS1	case	10	In Commercial Distribution
Package	00850005565192	GS1	box	10	In Commercial Distribution
Primary	00850005565185	GS1
Package	20850005565196	GS1	overpack	8	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K030921	000